The MEDGICarb-Study: Design of a multi-center randomized controlled trial to determine the differential health-promoting effects of low- and high-glycemic index Mediterranean-style eating patterns
Journal article, 2020

Adults with central adiposity and other features of the metabolic syndrome have a markedly elevated risk of developing type 2 diabetes (T2D) and cardiovascular disease (CVD). A Mediterranean-style healthy eating pattern (MED-HEP) and consumption of foods with a lower glycemic index (GI) are potential dietary approaches to curb the T2D and CVD epidemic. However, experimental evidence of the effectiveness of MED-HEP and of the contribution of GI towards improving indices of glucose homeostasis, especially among non-diabetic people, are lacking. Therefore, we developed the MedGI-Carb trial, a multi-center (Italy, Sweden, and United States) intervention in adults with at least two components of the metabolic syndrome (elevated waist circumference + one other component) that aims to improve markers of glucose homeostasis through dietary modification. All participants were randomized to consume an isocaloric high- or low-GI MED-HEP for 12 weeks. We hypothesized that indexes of insulinemia (primary outcome: postprandial insulin and glucose after standardized breakfast and lunch; secondary outcomes: fasting plasma glucose and insulin, HbA1c, 24-h continuous glucose monitoring) would be improved more with the low-GI versus the high-GI MED-HEP. Additionally, we hypothesized that consumption of a MED-HEP would improve other markers of cardiometabolic health and well-being (fasting blood pressure, fasting lipid profile, sleep quality, satiety, global metabolic alterations in the plasma metabolome, changes in the gut microbiota, subjective health and well-being), with no difference between groups. Collectively, the design of MEDGI-Carb allows several different research questions to be explored. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03410719.

Mediterranean diet

Glycaemia

Glucose control

Insulinemia

Cardiometabolic health

Author

Robert E. Bergia

College of Health and Human Sciences

I. Biskup

Chalmers, Biology and Biological Engineering, Food and Nutrition Science

Rosalba Giacco

University of Naples Federico II

Consiglo Nazionale Delle Richerche

Giuseppina Costabile

University of Naples Federico II

Savanna Gray

College of Health and Human Sciences

Amy Wright

College of Health and Human Sciences

Marilena Vitale

University of Naples Federico II

Wayne W. Campbell

College of Health and Human Sciences

Rikard Landberg

Chalmers, Biology and Biological Engineering, Food and Nutrition Science

Gabriele Riccardi

Consiglo Nazionale Delle Richerche

Contemporary Clinical Trials Communications

2451-8654 (eISSN)

Vol. 19 100640

Subject Categories

Endocrinology and Diabetes

Other Clinical Medicine

Nutrition and Dietetics

DOI

10.1016/j.conctc.2020.100640

More information

Latest update

9/15/2020